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Biocon — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Biocon (NSE: BIOCON, BSE: 532523), from US FDA records and exchange filings.
62
Compliance score (5 years) · how
8
USFDA-inspected plants on record
1
OAI classifications (5y)
0
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 07 Nov 2025 (Paravada plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Paravada Biocon Biosphere Limited |
3022125340 | VAI | 07 Nov 2025 | |
| Bengaluru Biocon Biologics Limited |
3015283245 | VAI | 03 Sep 2025 | |
| Bengaluru Biocon Limited |
3010164491 | VAI | 27 Sep 2024 | |
| Bangalore Biocon Limited |
1000172912 | VAI | 20 Sep 2024 | |
| Bengaluru Biocon Biologics Limited |
3003981475 | VAI | 26 Jul 2024 | |
| Paravada Biocon Limited |
3006400591 | VAI | 21 Jun 2024 | |
| Bengaluru Biocon Pharma Limited |
3013637926 | NAI | 02 Jun 2023 | |
| Sangareddy Biocon Limited |
3004956855 | NAI | 19 May 2023 |
Full USFDA timeline
19 Aug 2026
US approval
USFDA approval: NINTEDANIB ESYLATE
ANDA220118 — NINTEDANIB ESYLATE
Source: openFDA Drugs@FDA ↗
03 Aug 2026
US approval
USFDA tentative approval: CARBIDOPA AND LEVODOPA
ANDA220119 — CARBIDOPA,LEVODOPA
Source: openFDA Drugs@FDA ↗
22 Jul 2026
13 Jul 2026
US approval
USFDA tentative approval: PALBOCICLIB
ANDA220120 — PALBOCICLIB
Source: openFDA Drugs@FDA ↗
28 May 2026
01 May 2026
US approval
USFDA tentative approval: SITAGLIPTIN
ANDA218441 — SITAGLIPTIN
Source: openFDA Drugs@FDA ↗
28 Apr 2026
US approval
USFDA approval: ELTROMBOPAG OLAMINE
ANDA220660 — ELTROMBOPAG OLAMINE
Source: openFDA Drugs@FDA ↗
06 Apr 2026
17 Mar 2026
US approval
USFDA tentative approval: CABOZANTINIB
ANDA220121 — CABOZANTINIB
Source: openFDA Drugs@FDA ↗
11 Mar 2026
24 Feb 2026
09 Jan 2026
17 Nov 2025
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA219442 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
17 Nov 2025
US approval
USFDA tentative approval: TOFACITINIB CITRATE
ANDA219442 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
07 Nov 2025
VAI — minor issues
USFDA inspection classified VAI
Paravada · FEI 3022125340 · Biocon Biosphere Limited, Paravada — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 Oct 2025
US approval
USFDA approval: AUKELSO, BOSAYA
BLA761436 — DENOSUMAB-KYQQ (Efficacy)
Source: openFDA Drugs@FDA ↗
16 Sep 2025
03 Sep 2025
VAI — minor issues
USFDA inspection classified VAI
Bengaluru · FEI 3015283245 · Biocon Biologics Limited, Bengaluru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
15 Jul 2025
US approval
USFDA approval: KIRSTY
BLA761188 — INSULIN ASPART-XJHZ (Type 5 - New Formulation or New Manufacturer)
Source: openFDA Drugs@FDA ↗
14 May 2025
30 Apr 2025
09 Apr 2025
US approval
USFDA approval: JOBEVNE
BLA761175 — BEVACIZUMAB-NWGD (Type 5 - New Formulation or New Manufacturer)
Source: openFDA Drugs@FDA ↗
09 Apr 2025
21 Mar 2025
US approval
USFDA approval: NOREPINEPHRINE BITARTRATE
ANDA219443 — NOREPINEPHRINE BITARTRATE
Source: openFDA Drugs@FDA ↗
03 Mar 2025
03 Mar 2025
08 Jan 2025
US approval
USFDA tentative approval: OXCARBAZEPINE
ANDA218442 — OXCARBAZEPINE
Source: openFDA Drugs@FDA ↗
29 Nov 2024
US approval
USFDA approval: YESINTEK
BLA761406 — USTEKINUMAB-KFCE (Type 2 - New Active Ingredient)
Source: openFDA Drugs@FDA ↗
28 Oct 2024
27 Sep 2024
VAI — minor issues
USFDA inspection classified VAI
Bengaluru · FEI 3010164491 · Biocon Limited, Bengaluru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
20 Sep 2024
VAI — minor issues
USFDA inspection classified VAI
Bangalore · FEI 1000172912 · Biocon Limited, Bangalore — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
30 Aug 2024
US approval
USFDA approval: SACUBITRIL AND VALSARTAN
ANDA213680 — SACUBITRIL, VALSARTAN
Source: openFDA Drugs@FDA ↗
29 Aug 2024
26 Jul 2024
VAI — minor issues
USFDA inspection classified VAI
Bengaluru · FEI 3003981475 · Biocon Biologics Limited, Bengaluru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
21 Jun 2024
VAI — minor issues
USFDA inspection classified VAI
Paravada · FEI 3006400591 · Biocon Limited, Paravada — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
29 May 2024
US approval
USFDA approval: MICAFUNGIN SODIUM
ANDA216438 — MICAFUNGIN SODIUM
Source: openFDA Drugs@FDA ↗
20 May 2024
01 Mar 2024
28 Feb 2024
VAI — minor issues
USFDA inspection classified VAI
Bengaluru · FEI 3015283245 · Biocon Biologics Limited, Bengaluru — Pre-Approval Eval. of Animal Drugs and Food Additives (Veterinary)
Source: FDA Data Dashboard ↗
06 Feb 2024
US approval
USFDA approval: LIOTHYRONINE SODIUM
ANDA218070 — LIOTHYRONINE SODIUM
Source: openFDA Drugs@FDA ↗
29 Nov 2023
US approval
USFDA approval: MYCOPHENOLATE SODIUM
ANDA217031 — MYCOPHENOLATE SODIUM
Source: openFDA Drugs@FDA ↗
02 Jun 2023
NAI — clean
USFDA inspection classified NAI
Bengaluru · FEI 3013637926 · Biocon Pharma Limited, Bengaluru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
19 May 2023
NAI — clean
USFDA inspection classified NAI
Sangareddy · FEI 3004956855 · Biocon Limited, Sangareddy — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
26 Aug 2022
OAI — serious issues
USFDA inspection classified OAI
Bengaluru · FEI 3003981475 · Biocon Biologics Limited, Bengaluru — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/biocon